Chronic PancreatitisNCT04619511
Risk Factors for Post-ESWL and Post-ERCP Pancreatitis
An observational study of Chronic Pancreatitis and Risk Factors, run by Changhai Hospital.
Trial summary
The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis, Risk Factors, ERCP
- How many people
- 714 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2016to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive CP patients treated with both ESWL and subsequent ERCP during the same hospitalization between October 2016 and July 2019 were included.
Who may be able to join
- Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP
Who cannot join
- Patients with isolated pancreatic tail stone
- Patients with suspected or established malignancy
- Patients with pancreatic ascites
- Patients attending other interventional clinical trials
- Patients with non-correctable coagulation disorder
- Patients with pregnancy
About this study
Official title: Risk Factors for Post-ESWL and Post-ERCP Pancreatitis in Patients With Chronic Pancreatitis
The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.
- Conditions
- Chronic Pancreatitis, Risk Factors, ERCP, ESWL
- Medical subject headings
- Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis
The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.
Measured: up to 1 months
post pancreatic extracorporeal shock wave lithotripsy (ESWL) pancreatitis
The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start31 Oct 2016
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619511
- Sponsor's protocol ID
- ESWL&ERCP
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ru N, Qian YY, Zhu JH, Chen H, Zou WB, Hu LH, Pan J, Guo JY, Li ZS, Liao Z. Post-ESWL and post-ERCP pancreatitis in patients with chronic pancreatitis: Do they share the same risks? J Hepatobiliary Pancreat Sci. 2021 Sep;28(9):778-787. doi: 10.1002/jhbp.1013. Epub 2021 Jul 22.
PubMed 34242478
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Post-ESWL and Post-ERCP Pancreatitis in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT04619511
- Acronym / sponsor ID
- ESWL&ERCP
- Conditions
- Chronic Pancreatitis, Risk Factors, ERCP, ESWL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 714 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive CP patients treated with both ESWL and subsequent ERCP during the same hospitalization between October 2016 and July 2019 were included.
Key inclusion criteria (1 listed)
- Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP
Key exclusion criteria (6 listed)
- Patients with isolated pancreatic tail stone
- Patients with suspected or established malignancy
- Patients with pancreatic ascites
- Patients attending other interventional clinical trials
- Patients with non-correctable coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis
Time frame: up to 1 months
The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.
post pancreatic extracorporeal shock wave lithotripsy (ESWL) pancreatitis
Time frame: up to 1 months
The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 34242478Ru N, Qian YY, Zhu JH, Chen H, Zou WB, Hu LH, Pan J, Guo JY, Li ZS, Liao Z. Post-ESWL and post-ERCP pancreatitis in patients with chronic pancreatitis: Do they share the same risks? J Hepatobiliary Pancreat Sci. 2021 Sep;28(9):778-787. doi: 10.1002/jhbp.1013. Epub 2021 Jul 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Risk Factors, run by Changhai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (time frame: up to 1 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.